Production Quality Engineer Security Clearance

Position: Production Quality Engineer with Security Clearance
Location: Dulles

Production Quality Engineer Blu Omega is seeking a Production Quality Engineer to support compliant medical device manufacturing. This role operates within a medical device production environment and is responsible for establishing, maintaining, and improving quality systems and production quality processes to support regulatory compliance. Program Overview Program:
Medical device manufacturing quality and compliance Mission overview:
Ensure compliant production quality systems and processes for medical device manufacturing. Key Details

Location:

Dulles, VA Clearance:
No clearance required Work Authorization:
Applicants must be legally authorized to work in the United States without current or future sponsorship. Responsibilities
* Quality Systems & Regulatory Compliance (Primary Responsibility):
Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and FDA QMSR / 21 CFR Part 820
* Quality Documentation:
Author and maintain quality documentation, including SOPs, work instructions, and forms and records
* Paperless QMS Compliance:
Support and maintain compliance of a predominantly electronic (paperless) QMS
* Documentation Practices:
Ensure adherence to good documentation practices (GDP) and 21 CFR Part 11 (as applicable)
* Regulatory Support:
Support annual FDA establishment registration and device listing activities; assist with preparation, maintenance, and coordination of regulatory submissions, including 510(k) support, technical file/design dossier support, and submission documentation coordination with Regulatory Affairs, as applicable
* Audit Support:
Support internal audits and external audits (FDA, ISO certification, MDSAP readiness)
* Nonconformance, CAPA & Issue Resolution:
Investigate nonconforming product and process deviations; lead and support CAPA activities, including root cause analysis (RCA), corrective and preventive actions, and effectiveness verification
* Complaints:
Support complaint investigations and ensure feedback into manufacturing and process control
* Quality Event Resolution:
Drive timely and complete resolution of quality events
* Production Quality & Hands-On Problem Solving:
Work directly with production and technicians to investigate product and process issues, identify sources of variation and failure modes, implement corrective actions, and ensure production processes meet defined quality requirements
* Disposition & Risk Escalation:
Support real-time decision-making on product disposition and quality concerns; identify and escalate risks to product quality or regulatory compliance
* Process Validation & Control:
Develop, execute, and maintain IQ/OQ/PQ validation activities; support process changes and assess validation impact; ensure processes remain in a validated state; support development and maintenance of control plans and process monitoring methods

* Risk Management:

Support risk management activities aligned with ISO 14971, including participation in Process FMEA (PFMEA) and risk assessment for manufacturing and process changes; ensure risk-based decision making in quality and production activities
* Supplier Quality (Supporting Role):
Support incoming inspection processes and acceptance criteria; assist in supplier issue investigations and corrective actions; collaborate with supply chain and engineering to ensure material quality
* Training & Workforce Development:
Train and support technicians performing assembly, testing, and inspection; develop training materials and ensure competency and training effectiveness; promote best practices in documentation, quality, and process adherence

Required Qualifications
* Bachelor's degree in Engineering or related technical field
* 5-8 years of experience in medical device quality engineering (ISO 13485 / FDA regulated environment) or other medical products quality engineering field
* Strong working knowledge of: CAPA and nonconformance systems, root cause analysis methodologies, and quality system documentation
* Experience supporting or leading:
Process validation (IQ/OQ/PQ), audits (internal or external), and FDA annual establishment registration and device listing, including 510(k) support, technical file/design dossier support, and submission document coordination with Regulatory Affairs
* Strong problem-solving skills with a hands-on approach to issue resolution

Preferred Qualifications
* Experience with manufacturing processes (machining, assembly, prototyping, etc.)
* Familiarity with mechanical design or CAD tools (e.g., Solid Works)
* Exposure to electronics testing (multimeters, oscilloscopes)
* Experience with test systems, automation, or programming (Python, C/C++)
* Familiarity with optical systems or measurement technologies
* Experience in startup or early-stage manufacturing environments Compensation Salary Range: $115,000 - $200,000 Final compensation is based on technical skills, experience, education, certifications, and clearance. Blu Omega Benefits & Perks
* Medical,…